OR WAIT null SECS
November 06, 2017
The agency published guidance regarding OTC aspirin products that have cardiovascular-related images in their labels.
November 02, 2017
Data governance is necessary for compliance with current regulatory expectations for data integrity in pharmaceutical R&D and manufacturing organizations.
The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.
Creating a quality culture can prevent the costs and challenges associated with receiving a consent decree.
October 31, 2017
A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.
October 25, 2017
FDA sent a warning letter to Ridge Properties, LLC, after inspectors found a variety of current good manufacturing practice violations at the company’s Salem, OR facility.
October 23, 2017
EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.
October 11, 2017
The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.
The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.
FDA published guidance on the format and content of REMS documents.